Actively Recruiting
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
Led by Shengjing Hospital · Updated on 2024-01-03
136
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.
CONDITIONS
Official Title
Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Treatment-nafve with early or locally advanced triple-negative invasive breast cancer confirmed by latest ASCO/CAP guidelines
- Clinical stage II-III breast cancer with measurable lesions per RECIST 1.1
- ECOG performance status 0-1
- Able to tolerate preoperative and postoperative adjuvant radiotherapy as assessed by a radiologist
- Adequate organ function
- Willing to voluntarily participate, provide informed consent, and comply with study requirements
You will not qualify if you...
- Metastatic breast cancer or bilateral breast cancer
- Inflammatory breast cancer or occult breast cancer
- Received any anti-tumor therapy (chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy, or tumor embolization) within 12 months before signing consent
- Previous treatment with PD-1/PD-L1 antibody, CTLA-4 antibody, or other PD-1/PD-L1 inhibitors
- Pregnant, lactating, or fertile female with a positive pregnancy test or unwilling to use effective contraception during the trial
- History of neurological or psychiatric disorders including epilepsy, dementia, psychotropic drug abuse, or alcoholism
- HIV infection, AIDS, positive hepatitis B or C tests as specified
- Any condition deemed by the investigator to make participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110022
Actively Recruiting
Research Team
C
Caigang Liu, Dr.
CONTACT
N
Nan Niu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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